Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain

This study seeks to evaluate the safety and efficacy of genicular artery embolization (GAE) as a treatment for patients with chronic pain following primary total knee arthroplasty (TKA) or revision TKA at 6 months as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS).

Study Overview

• Status: Withdrawn
• Conditions: Arterial Occlusion; Knee Pain Chronic; Knee Swelling Pain
• Intervention / Treatment: Device: Embozene Microspheres

Detailed Description

This is a single center, single arm, prospective pilot study evaluating the safety and efficacy of genicular artery embolization (GAE) for treatment of chronic pain following primary total knee arthroplasty (TKA) or revision TKA. Following screening, eligible participants will be offered enrollment. Patients who demonstrate baseline imaging findings of knee synovitis either on US, MRI, or both modalities will be offered GAE. Genicular artery embolization will be performed using a SeQure® microcatheter (Guerbet LLC, Villepinte, France) using Embozene microspheres (Varian Medical Systems, Palo Alto, CA).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ambulatory
2. History of total knee arthroplasty or revision arthroplasty in the symptomatic knee
3. Moderate to severe knee pain: pain VAS ≥50 mm
4. Knee pain resistant to at least 3 months of conservative therapy including pharmacologic therapy or intra-articular injection.
5. Absence of pregnancy at time of screening as determined by urine HCG
6. Provision of signed and dated informed consent form
7. Willing, able, and mentally competent to provide informed consent and to tolerate angiography, US, and MRI.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. History of severe peripheral arterial disease symptoms including claudication, diminished or absent lower extremity pulses, leg numbness or weakness or known arterial atherosclerosis or occlusion that would limit selective angiography
2. History of inflammatory arthropathy such as rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus
3. Presence of non-MRI compatible devices (e.g., cardiac pacemaker).
4. Known history of anaphylaxis to iodinated or gadolinium-based contrast agents
5. BMI greater than 50
6. Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 obtained within 30 days of procedure.
7. Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.5 within 30 days of procedure
8. Active systemic or local knee infection
9. Pregnant or intent to become pregnant during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Genicular artery embolization; Study participants will undergo genicular artery embolization (GAE) for treatment of chronic moderate to severe pain following knee arthroplasty or revision arthroplasty. Embolization will be performed using Embozene Microspheres.

Device: Embozene Microspheres; Embozene Microspheres are manufactured by Varian Medical Systems (Palo Alto, CA). These microspheres are non-resorbable hydrogel microspheres coated with polyzene-F. Embozene microspheres are approved for use in treating arteriovenous malformations, hypervascular tumors such as uterine fibroids and hepatomas, and prostatic arteries in patients with benign prostatic hyperplasia. One of the causes of chronic pain in the setting of a knee arthroplasty may be increased blood flow to the specific area(s) of pain. The purpose of this procedure is to reduce blood flow (embolize) to specific parts of the knee which are contributing to your pain. This procedure is performed by infusing the Embozene particles into specific knee arteries (genicular arteries) in the region of knee pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS - Pain subscale KOOS Scale - Pain	Estimate the effect of genicular artery embolization on the change in knee pain, as assessed by the KOOS, at 6 months post vs. pre-intervention, in patients with chronic knee pain following TKA	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Scale	Estimate the effect of genicular artery embolization on the change in knee pain, as assessed by the VAS scale, at 1 week, 1, 3, and 6 months, in patients in patients with chronic knee pain following TKA.	6 months
Analgesic Utilization	Estimate the effect of genicular artery embolization on analgesic utilization as measured by morphine equivalents and non-steroidal anti-inflammatories utilization	6 months
KOOS - Non-Pain Components	Estimate effect in non-pain components of the KOOS score (KOOS Symptoms, KOOS ADL, KOOS Sport ADL, and KOOS QOL) by comparing these scores at 1 week, 1,3, and 6 months to the pre-procedure score.	6 months
MHI-5	Assess for associations between mental health and post TKA pain as assessed by the MHI-5 by comparing scores at 1 week, 1, 3, and 6 months to the pre-procedure score.	6 months
CRP & IL-6	Estimate the effect of genicular artery embolization on CRP and IL-6, by comparing baseline laboratory values to 6-month post procedure values.	6 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Guerbet
• Investigators: Principal Investigator: Yan Epelboym, MD, MPH, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022P000238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes